Informed Consent and Health Literacy Workshop Summary (2015) / Chapter Skim
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3 The Current State of Informed Consent in Research and Treatment
3 The Current State of Informed Consent in Research and Treatment
Pages 23-52
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From page 23... ...
Sandra Crouse Quinn, associate dean for academic affairs, professor of family science, and senior associate director of the Center for Health Equity at the University of Maryland, College Park, described strategies for improving the informed consent process to help increase minority participation in clinical trials, and Alicia Fernandez, professor of clinical medicine at the University of California, San Francisco, highlighted the disproportionately negative impact that poor informed consent processes have on the medical treatment that minorities receive. An open discussion followed the four presentations.
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From page 24... ...
A good informed consent process should also provide potential participants adequate opportunity to ask questions and consider whether to participate and should ensure that agreeing to participate is completely voluntary. She also noted that many complex learning activities go on in informed consent that impact the quality and success of the consent process.
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From page 25... ...
For example, failing to describe the nature of the research and the scientific reasons for it could potentially affect recruitment and retention. She noted that researchers need to conduct exit interviews to ascertain why participants withdraw from studies and determine if the informed consent process played a role in that decision and whether there was a disconnect between an individual's experiences in the study and what was learned through the informed consent process.
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From page 26... ...
Another sublime concern of hers is that informed consent handled poorly fails to engage participants as true partners and may lead to their sense of objectification or "commoditization" that can then promote distrust and anger. There are several areas, said Goldkind, where further research is needed in order to improve the informed consent process.
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From page 27... ...
The NCI also found that people who were familiar with clinical trials were more inclined to want to be part of clinical research. Goldkind said that this finding goes back to one of her earlier points that educating people regarding what clinical research is about on a larger, community-wide basis could provide a contextual framework for people to understand information given to them within the informed consent process.
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From page 28... ...
It is also important, Goldkind said, to recognize the role that the larger community, such as patient advocacy groups, community-based advisory boards, and diseasespecific foundations, can play in improving the informed consent process beyond improving the actual consent document. She also suggested that the field should reach out to other disciplines and co-opt successful research tools from the social-behavioral and decisional sciences, successful teaching techniques from educators, and effective communication skills.
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From page 29... ...
She said that research shows that there is poor recall and understanding of information presented during the informed consent process and that there is a lack of knowledge, particularly among racial and ethnic minorities, about research and research terms. When the consent process is done well, these challenges can be overcome, and trust can be built between researcher and participant, but when done poorly, mistrust can be reinforced by the consent process.
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From page 30... ...
"Community members wanted more meetings and more opportunities to talk about the consent process," said Quinn. They wanted to talk with other participants or potential participants in group discussions, and they saw videos as potentially helpful (see Figure 3-1)
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From page 31... ...
One disturbing finding was that 32 percent of the researchers did not assess understanding at all. Summarizing these findings, Quinn said that what is known about informed consent is that participants may have incomplete comprehension of information delivered during the informed consent process and that there
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From page 32... ...
Second, it is important to increase satisfaction using such methods as one-on-one discussions, multiple meetings, pictures, and summaries. "Our team firmly believes that recruitment and the informed consent process are the beginning of a relationship, and if we begin that relationship in a way that fosters trust and understanding and dialogue, we believe that will ultimately play out in a successful completion of that research subject," said Quinn.
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From page 33... ...
The curriculum then answers questions about why community members should participate in research and what informed consent is, including a glossary of terms and the 10 key elements of the informed consent process and the means to identify them. The curriculum then provides a list (which can be downloaded and printed)
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From page 34... ...
In conclusion, Quinn said that she and her colleagues believe that a several-pronged process is essential to overcoming underrepresentation of minorities in clinical research and that the informed consent process can be one of those prongs. "There is a broader educational effort that is important, and then there are the specific components of improving informed consent when somebody comes in to talk about participation," said Quinn.
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From page 35... ...
"Informed consent is the platform from which we work to help ensure that patients are involved in medical decisions and that these decisions reflect their values and preferences," Schenker said. There are many documented failures of informed consent, according to Schenker, including the failure to achieve adequate patient understanding that can lead to medical errors or the receipt of preference-discordant care.
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From page 36... ...
"I would propose that this approach can also be more efficient if each member of the team is charged with achieving a smaller piece of the consent process at the appropriate time," she added. Turning to the "when" of informed consent, Schenker noted that previous speakers at the workshop had addressed the problem of obtaining informed consent immediately prior to a planned procedure.
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From page 37... ...
"When we talk about informed consent as a process, I think it is important that we allow time for this process to occur." In discussing the "what" of informed consent, Schenker noted that the current focus of consent discussions and consent forms is on risks. She said that for a high-risk procedure such as LVAD surgery, it is appropriate to discuss these risks in detail.
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From page 38... ...
Ask-tell-ask starts by inviting the patients to share FIGURE 3-5 Aligning patient goals and outcomes. NOTE: LVAD = left ventricular assist device.
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From page 39... ...
INFORMED CONSENT AND PATIENTS WITH LIMITED ENGLISH PROFICIENCY4 Alicia Fernandez University of California, San Francisco Alicia Fernandez began this session's final presentation by noting that there are no national or multicenter data on how best to overcome language barriers in conducting the treatment-related informed consent process. She also explained that the definition of limited English proficiency comes from the U.S.
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From page 40... ...
Some 60 percent of this population have less than a high school education -- in studies by Fernandez's group at San Francisco General Hospital, the mean education level for patients with diabetes was third grade, for example -- and about 6.6 million individuals with low English proficiency fall below the poverty FIGURE 3-6 Percentage of the U.S. population speaking a language other than English at home who spoke English less than "very well," by state, 2007.
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From page 41... ...
health practices, including informed consent practices, and are less likely to question physicians, Fernandez said. Fernandez listed four options for navigating language barriers: get by with limited language skills and gestures; use untrained interpreters, such as family and untrained staff; hire professional interpreters; and rely on bilingual clinicians.
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From page 42... ...
. In contrast, said Fernandez, there is substantial evidence from audiotape studies that professional interpreters provide more accurate information than ad hoc interpreters and that the use of professional interpreters increases patient and physician satisfaction compared to when ad hoc interpreters or no interpreters are used (Karliner et al., 2007; Tschurtz et al., 2011)
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From page 43... ...
In a study that she and her colleagues conducted at Kaiser Permanente of Northern California, 35 percent of low-Englishproficiency patients with diabetes who were treated by a physician who did not speak Spanish reported a lack of trust, compared to only 16 percent of those treated by a Spanish-speaking physician who reported a lack of trust (Schenker et al., 2010)
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From page 44... ...
show that patients with diabetes treated by language-discordant TABLE 3-4 Suboptimal Communication Resulting from LanguageDiscordant Care English proficient LEP LEP-LC LEP-LD n = 8,116 n = 522 P value n = 210 n = 153 P value Lack of trust 26% 25% 0.37 16% 35% <0.0001 in MD Treated 2% 12% <0.001 9% 20% 0.001 poorly because language MD not 28% 30% 0.31 29% 39% 0.04 showing respect MD not 33% 28% 0.02 26% 32% 0.24 listening NOTE: LC = language concordant; LD = language discordant; LEP = low English proficiency; MD = physician. SOURCE: Schenker et al., 2010.
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From page 45... ...
Regarding how to address the challenges regarding individuals with limited English proficiency, who are among the most vulnerable of all patients, Fernandez said that to start, more data are needed on the state of the problem and on what is happening nationwide. There is also a need, she said, for national standards for interpreters and the mandatory use of certified professional interpreters for high-risk treatments and procedures, including high-risk outpatient decisions, such as a decision to start chemotherapy.
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From page 46... ...
"Informed consent is often the trigger that gets doctors thinking about this." She added that, in her opinion, there is time to start the consent process in advance for many kinds of procedures. In the case of destination LVAD surgery, for example, heart failure is often a chronic disease, and most of these patients have been seen in the hospital repeatedly, long before the decision is made to implant an LVAD.
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From page 47... ...
"The benefits may be not simply benefits to the individual but benefits to the community or to broader society." Goldkind added, citing anecdotal experiences she has had working with disease-based foundations and groups in a number of settings where risk was high, that in some cases it was clear that the people who were going to be enrolled in research were not going to be the beneficiaries of that immediate intervention. "What struck me was how very engaged the groups were and how much input there was in terms of design, the informed consent process, the language used, and the understanding of what risk levels they were willing to tolerate beyond what we actually expected they would [be willing to incur]
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From page 48... ...
Thanks to technology solutions such as Skype and tablet computers, it should be possible to make use of interpreters with skill in any language and have interpreted conversations in real time wherever the patient is. She said that the private sector needs to step up to make this type of capability broadly available, and she added that "the research is unequivocal that video or in-person are both much better than telephone interpreters." In response to a question from Dreyer about whether there are any interventions in the clinical as opposed to the research setting that get people to take more time during the consent process, Schenker replied that it is sometimes difficult to find more time in busy clinical settings.
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From page 49... ...
Ruth Parker responded that what she hears in the patient-centered community environment is that the focus still needs to be on helping patients and prospective participants better understand the consent process at the community level. Parker then asked Goldkind if the same informed consent processes will work in the clinical and research settings, given that research studies are mostly about determining safety and efficacy and that informed consent in the clinical setting has more to do with personal liberty and doing no harm.
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From page 50... ...
' This is very complicated and cannot be fixed by a form," she said. Turning to the role that regulations may or may not play in complicating informed consent forms, Andrew Pleasant, senior director for health literacy and research at the Canyon Ranch Institute and a roundtable member, noted that in his work as a community researcher he interacts with multiple IRBs across the country, and they all apply the existing regulations differently.
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From page 51... ...
To the extent that we can rethink our approach and extend beyond informed consent to informed choice, this would be valuable."
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